Responsibilities:

Maintain an efficient quality system to meet the requirements of regulations and customer needs, ensuring the renewal of quality certificates such as ISO 9001 and GSP license.

Lead customer audits of Thermo Fisher and coordinate the customer audits to manufacturers.

Lead the timely completion of quality agreements and questionnaires.

Handle customer complaints, AE, recall, PRER, and ensure regulatory compliance.

Manage quality operation activities, including product quality judgment and return evaluation, derogation approval, as well as related 3PL quality management.

Lead the quality management of computerized system validation and cold-chain validation.

Indirect supplier quality management, including supplier quality evaluation and quality audits.

Support business projects as a quality BP to deliver professional quality responses and ideas

Requirements:

Bachelor's degree or above in Medicine, Pharmacy, Bioengineering, or a related field (MD preferred).

More than 8 years of experience in quality-related functions.

Knowledge of regulations pertaining to quality management.

Over 5 years of experience in people management.

workable English.

Soft Skills:

Demonstrated experience in collaborating across different departments and working with various individuals or groups involved.

Excellent communication and driven skills.

Demonstrated proficiency in effective problem-solving and decision-making, along with strong analytical skills and a focus on data-driven approaches.